Azathioprine recalls

The FDA has published 2 recalls involving Azathioprine since 2014. The latest was reported on 14 May 2014. Most were for labeling errors. Boehringer Ingelheim Roxane has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls2since 2014

Last 12 months0reported

Class I00% of total

Ongoing0latest 14 May 2014

Recalls per month, last 24 months

click a bar for that month

0Dec '24 0 0 0Mar 0 0 0Jun 0 0 0Sep 0 0 0Dec 0 0 0Mar 0 0 0Jun 0 0 0Sep 0 0

Severity split

Class I 0 0%Class II 1 50%Class III 1 50%

Why azathioprine is recalled

Labeling Errors150%
Other Reasons150%

Companies

Boehringer Ingelheim Roxane150%
Aidapak Services150%

By year

20142100%

All azathioprine recalls, newest first

2 total

Reported	Class	Recall	Company	Reason	Where
14 May 2014Drug	CLASS III	Azathioprine Tablets USP, 50 mg recalled by Boehringer Ingelheim Roxane	Boehringer Ingelheim Roxane	Other	Nationwide
29 Jan 2014Drug	CLASS II	azaTHIOprine, Tablet, 50 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states

Should you stop taking Azathioprine?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.